NCT00720239

Taliderm Dressing for Venous Ulcers

Safety and Wound Healing Efficacy of the TalidermR Wound Dressing a Poly-N-acetyl Glucosamine-derived Membrane Material in Humans With Venous Stasis Ulcers: a Pilot Study.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing, a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in humans with venous stasis ulcers.

Conditions

• Venous Stasis Ulcers
• Venous Insufficiency

Interventions

Type	Name	Description
OTHER	Taliderm wound healing dressing	Taliderm wound healing dressing will be applied to the wound site as follows depending on assignment to group: Control group receives no intervention. Experimental Group 1 (n = 10) will receive TalidermR only one time at the beginning of the treatment phase. Experimental Group 2 (n = 10) will receive TalidermR to the wound every other week during the treatment phase. Experimental Group 3 (n = 10) will receive TalidermR to the wound every three weeks during the treatment phase.

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-09-01
• Completion: 2010-08-01
• First posted: 2008-07-22
• Last updated: 2013-02-22

Locations

1 site across 1 country: United States